An observational study in Myopia and Quality of Life, sponsored by Region Örebro County. Recruiting at 1 site in Sweden. Open to participants aged Up to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Region Örebro County · Observational
Society has become increasingly digital, and many everyday services have been replaced by digital self-service solutions. This puts greater demands on our vision and our ability to interpret what we see. At the same time, the number of children with nearsightedness (myopia) has increased rapidly. In some parts of Asia, as many as 60-70% of students in seventh grade are nearsighted, and a similar trend may develop in Europe.
Nearsightedness is becoming a growing challenge in pediatric eye care. High myopia can lead to complications that require early detection and prevention. There are now several ways to slow down its progression, such as special contact lenses, glasses, and eye drops. However, the scientific evidence for these treatments varies, and there are currently no national or Nordic guidelines on how to use them. In addition, myopia may have a major impact on children's quality of life.
Currently, there is no validated Swedish questionnaire that measures vision related quality of life across all age groups in children and adolescents. To address this, researchers in the United States developed the Pediatric Eye Questionnaire (PedEyeQ) in 2019. It is already available in English and Spanish and takes into account both the child's and the parent's perspectives on vision and daily life.
The aim of this study is to translate, culturally adapt and test the PedEyeQ in Swedish children and adolescents, and to investigate how common refractive errors, especially nearsightedness - are today compared to 20-30 years ago.
The study will include 300 healthy children and adolescents aged 0-17 years, divided into three age groups: 0-4 years, 5-11 years, and 12-17 years. Participants will be recruited through child health centers, preschools, and schools in the Örebro region.
All participants will visit the eye clinic for a detailed eye examination, including:
Children and parents will also answer questions about how the child's vision affects everyday life and wellbeing. For the youngest children (0-4 years), only parents will answer the questions.
The PedEyeQ will be translated into Swedish following the International Society for Pharmacoeconomics and Outcome Research (ISPOR) guidelines to make sure it is culturally relevant and easy to understand. The Swedish version will then be tested to ensure it is accurate and reliable.
All information collected in the study will be stored securely and anonymously. The results will also be compared with data from a similar cohort conducted in the 1990s to see if vision problems have become more common over time.
This project will provide new knowledge about children's vision and quality of life in Sweden. A validated Swedish version of the PedEyeQ can be used both in healthcare and research to better understand how vision affects children's daily lives. The study will also offer updated information on the frequency of refractive errors among Swedish children and adolescents - knowledge that is essential for developing preventive strategies and improving eye care for the future.
Society has undergone extensive digitalization, in which many service functions have been replaced by digital self-service solutions. This development requires a good visual function and on the ability to interpret visual information. Concurrently, there has been a marked increase in nearsightedness (myopia) among children. In parts of Asia, 60-70% of students in seventh grade are myopic, and a similar trend may emerge in Europe.
The increase of myopia might become major challenge within pediatric ophthalmology. High myopia can lead to vision-related complications that require early diagnosis and preventive measures. Preventive interventions-such as specialized contact lenses, spectacle designs, and pharmacological treatments as for example low-dose atropine, are now available on the market. However, the scientific evidence supporting these methods varies, and there is currently no national or Nordic consensus regarding their implementation. Furthermore the condition may have substantial implications for affected children's quality of life.
At present, there is no validated Swedish-language instrument for assessing vision-related quality of life in children and adolescents that encompasses all age groups, despite the widely recognized importance of such measures from both a Patient-Reported Outcome Measure (PROM) and Patient-Reported Experience Measure (PREM) perspective. A new questionnaire, the Paediatric Eye Questionnaire (PedEyeQ) was developed in the United States in 2019 for children and adolescents aged 0-17 years. Since its introduction, it has been used in English and subsequently translated into Spanish. The questionnaire comprises four domains measuring different aspects of vision-related quality of life, with each domain consisting of ten questions. To achieve a comprehensive understanding, the questionnaire incorporates both the child's and the parent's perspectives, and it includes separate age-appropriate versions for different developmental stages.
The aim of this study is to validate the PedEyeQ on a healthy Swedish cohort and to study the prevalence and changes in the amount of refractive errors in the same cohort and compare them to another healthy cohort investigated two decades ago.
Validation of PedEyeQ: We intend to translate the PedEyeQ into Swedish and validate the instrument in a cohort of healthy children and adolescents born in Sweden. The study group will consist of 300 participants aged 0-17 years, divided into the following age-based subgroups corresponding to the PedEyeQ versions: 0-4 years, 5-11 years, and 12-17 years, with 100 participants in each group. Efforts will be made to ensure that sex distribution, ethnicity, socioeconomic status, and birth parameters reflect those of the general population. Recruitment will primarily take place through child healthcare centers, preschools, and schools in Örebro and surrounding areas.
Participants will be invited to the ophthalmology clinic for a comprehensive examination, including: assessment of distance and near visual acuity, optical coherence tomography (OCT) to document retinal structure, PedEyeQ for assessment of vision-related quality of life, and the Pediatric Quality of Life Inventory (PedsQL) for assessment of general quality of life.
For children aged 0-4 years, only parents will complete the quality-of-life assessment. In the older groups, both the child and the parents will complete the questionnaires independently, allowing for comparison between the two perspectives.
The validation process will follow the International Society for Pharmacoeconomics and Outcome Research (ISPOR) recommendations for the translation and cultural adaptation of questionnaires. The original American PedEyeQ will be translated using a forward-backward translation procedure. The forward translation from English to Swedish will be carried out by a physician with strong subject knowledge and proficiency in both languages. The translation will be reviewed and proofread by an expert panel consisting of the principal supervisor and co-supervisors. The finalized Swedish version will then be back-translated into English. Emphasis during translation will be placed on conceptual and cultural equivalence, rather than literal translation. The research team will discuss any discrepancies between the original and back-translated versions to establish a final Swedish version of the instrument.
The Swedish questionnaire will then be tested in the described healthy study population. To ensure that participants can understand and adequately respond to the items, all participants will take part in a cognitive interview regarding the questionnaire. Following data collection, psychometric analyses will be conducted to evaluate validity, reliability, reproducibility, responsiveness, and factor structure.
Prevalence of refractive errors - The cohort described above will be recruited as previously outlined. In addition to completing the questionnaires, all participating children will undergo a comprehensive ophthalmological examination according to a standardized protocol, which includes measurements of several factors influencing ocular refraction.
The examination will include: Assessment of distance and near visual acuity, autorefractor measurements both with and without cycloplegia (meaning after administration of dilating eye drops to temporarily suspend accommodation and obtain accurate refraction values), Optical Coherence Tomography (OCT) to measure retinal thickness and to detect potential pathology such as edema, deposits, or thinning, Axial length measurement, non-invasive corneal mapping of corneal thickness, curvature, and refractive power using Pentacam, measurement of intraocular pressure using a non-contact, non-anesthetic method, and assessment of contrast sensitivity.
All collected data will be stored in a dedicated, pseudonymized research database (FoU database). Descriptive analyses will be performed to determine the prevalence of refractive errors within the study population. The cohort will also be compared to a corresponding reference group examined during the 1990s, in order to assess potential temporal changes in the prevalence of refractive errors among children and adolescents.
For statistical analysis, the Mann-Whitney U test will be used to compare continuous variables, while Fisher's exact test and the Chi-square test will be applied for comparisons of dichotomous variables. Regression analyses will be conducted to explore associations between risk factors and myopia, as well as relationships between myopia and quality of life.
Furthermore, the described cohort will serve as a reference population, allowing for the extraction of age- and sex-matched control groups for future pediatric ophthalmological studies.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's planned enrollment of 300 is above the median of 150 across 204 observational studies indexed under Myopia.
Browse Myopia studies →Region Örebro County is the lead sponsor of 124 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study group will be selected from randomised preschools, and schools in Örebro and surrounding areas and we aim to collect a cohort as equal as possible compared to health children in general. Efforts will be made to ensure that sex distribution, ethnicity, socioeconomic status, and birth parameters reflect those of the general population.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The study group will consist of 300 participants aged 0-17 years, divided into the following age-based subgroups corresponding to the PedEyeQ versions: 0-4 years, 5-11 years, and 12-17 years, with 100 participants in each group. Efforts will be made to ensure that sex distribution, ethnicity, socioeconomic status, and birth parameters reflect those of the general population. Recruitment will primarily take place through child health centers, preschools, and schools in Örebro and surrounding areas.
Diagnostic Test: ophthalmological examination
The examination will include: Assessment of distance and near visual acuity, Autorefraction measurements both with and without cycloplegia (i.e., after administration of dilating eye drops to temporarily suspend accommodation and obtain accurate refraction values), Optical Coherence Tomography (OCT) to measure retinal thickness and to detect potential pathology such as edema, deposits, or thinning, Axial length measurement, Non-invasive corneal mapping of corneal thickness, curvature, and refractive power using Pentacam,Measurement of intraocular pressure using a non-contact, non-anesthetic method, and Assessment of contrast sensitivity. It will also include questionnaires as the PedEyeQ described earlier, the PedQoL.
Prevalence of refractive errors
Time frame: 1 day
Started Oct 2024 (actual). Primary completion is estimated for May 2027, 31 months after the start.
Of 87 non-industry observational studies under Myopia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 90. This study's planned 31 months is above that.
Counting every sponsor, half of 96 studies reached it within 24 months; a quarter within 10 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
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